Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Non-inferiority
研究概览
简要总结
Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study
详细描述
Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study to demonstrate safety and effectiveness based on non-inferiority of the study device (Emboliner EPD) compared to the control device (Sentinel CPS) in terms of a 30-day composite major adverse cardiac and cerebrovascular events (MACCE) rate - defined as all death, stroke and Stage 3 acute kidney injury - evaluated on a per-patient basis, post-TAVR procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for treatment for symptomatic severe aortic stenosis using a FDA-approved TAVR valve according to current guidelines
- •Consented to the TAVR procedure
- •Subject and physician agree that subject will return for required post-procedure follow-up
- •Willing to participate in study and provide signed EC/IRB-approved informed consent
- •Eighteen (18) years or older at the time of consent
排除标准
- •Not undergoing a planned TAVR via transfemoral access
- •Severe allergy or hypersensitivity to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, nitinol, and/or contrast agents that cannot be pre-medicated
- •Uncorrected bleeding disorder
- •Hypercoagulation status that cannot be corrected by additional peri-procedural heparin
- •Myocardial infarction (MI) diagnosis <30 days prior to study procedure
- •History of substance abuse that may cause non-compliance with the protocol or confound the data interpretation
- •Cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension (systolic blood pressure <90 mmHg) at time of screening
- •History of a stroke < 180 days prior to study procedure
- •Active peptic ulcer or history of upper gastrointestinal (GI) bleeding < 90 days prior to study procedure
- •Congenital unicuspid aortic valve
- •Porcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the arch
- •Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
- •Current leukopenia, acute anemia, thrombocytopenia, history of chronic bleeding diathesis, or coagulopathy that requires treatment
- •Hypertrophic cardiomyopathy with or without obstruction
- •Left ventricular ejection fraction (LVEF) ≤20%
- •Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
- •Active infection or endocarditis
- •Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults
- •Carotid stent placement or endarterectomy performed <180 days prior to study procedure.
- •Severe renal insufficiency (creatinine >3.0 mg/dL or GFR <30 mL/min) or patient on dialysis
- •Planned treatment with another investigational device or procedure during the study period
- •Balloon valvuloplasty (BAV) within 30 days of the procedure
- •Any planned surgical or interventional cardiac procedure (e.g., concurrent coronary revascularization or AF ablation) during the TAVR procedure, within 30 days before or after the TAVR procedure
- •Emergency surgery for any reason
- •Pregnancy, lactation or intent to become pregnant during study participation
- •Unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment
- •Investigator considers participation in the study not to be in the subject's best interest
- •Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol
- •Presence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature
研究组 & 干预措施
Emboliner Embolic Protection Device
Emboliner embolic protection device to be used during TAVR procedures for stroke prevention
干预措施: Emboliner Embolic Protection (Device)
Sentinel Cerebral Protection System
Sentinel Cerebral Protection System to be used during TAVR procedures for stroke prevention
干预措施: Sentinel Cerebral Protection (Device)
结局指标
主要结局
Non-inferiority
时间窗: Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate.
Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate. K4: Description Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate. 30 Days
次要结局
- Non-inferiority VARC-2(30 Days)
- Debris Capture(30 Days)